RANITIDINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Pieejams no:

PRO DOC LIMITEE

ATĶ kods:

A02BA02

SNN (starptautisko nepatentēto nosaukumu):

RANITIDINE

Deva:

300MG

Zāļu forma:

TABLET

Kompozīcija:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 300MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/30

Receptes veids:

Prescription

Ārstniecības joma:

HISTAMINE H2-ANTAGONISTS

Produktu pārskats:

Active ingredient group (AIG) number: 0115150001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2023-07-10

Produkta apraksts

_ _
RANITIDINE_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
PR RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-receptor antagonist
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
September 18, 2019
Submission Control No: 229390
RANITIDINE_ _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................12
PART II: SCIENTIFIC INFORMATION
................................................................................13
PHARMACEUTICAL INFORMATION
..........................................................................13
CLINICAL TRIALS
..........................................................................................................14
DETAILED PHARMACOLOGY
................